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Pulmonary Vein (PV) Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation

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Johns Hopkins University

Status

Completed

Conditions

Atrial Fibrillation
Radiofrequency Ablation

Treatments

Procedure: usual PV ablation
Procedure: Box isolation of pulmonary veins

Study type

Interventional

Funder types

Other

Identifiers

NCT01091597
NA_00008424

Details and patient eligibility

About

Curative catheter ablation has been established as an effective therapeutic option for atrial fibrillation (AF) that is resistant to pharmacologic rhythm or rate control. However, standard ablative approaches targeting the pulmonary veins (PVs) are associated with a success rate as low as 40%. In a recent study, Kumagai et al. described a new approach of catheter ablation of AF isolating the posterior left atrium including all PVs (called Box Isolation). In Kumagai's study, 46 patients with symptomatic AF underwent box isolation. At 6 months follow up, 43 of 46 patients (93%) were arrhythmia free without antiarrhythmic drugs, with a single procedure success rate of 87% (40/46). This study provided new evidence supporting the hypothesis that the posterior wall is of high importance for the maintenance of AF. The aim of the investigators study is to determine the efficacy of two different approaches of catheter ablation (Standard PV Isolation vs. Box isolation) for the treatment of chronic AF.

Enrollment

30 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing clinically indicated pulmonary vein ablation for atrial fibrillation.

Exclusion criteria

  • Unable to understand consent form. Not scheduled for clinically indicated pulmonary vein ablation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

usual ablation
Active Comparator group
Description:
Wide-area circumferential ablation of the pulmonary veins
Treatment:
Procedure: usual PV ablation
Box isolation of the pulmonary veins
Experimental group
Description:
Single Box lesion set encompassing all four pulmonary veins and the posterior wall of the left atrium.
Treatment:
Procedure: Box isolation of pulmonary veins

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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